UNC Kidney Center, SQI Diagnostics enter validation agreement for Vasculitis Test

The UNC Kidney Center will act as a third party evaluator for SQI’s multiplexed, automated approach for biomarker detection in vasculitis.

SQI Diagnostics Inc. is a medical systems automation company focused on evolving laboratory-based autoimmune biomarker testing.

Ronald J. Falk, MD, Director of University North Carolina Kidney Center, will be the principal investigator of the two-week validation study. Dr. Falk has characterized several of the diagnostic and prognostic markers for vasculitis found in blood serum, and has been involved in establishing internationally recognized clinical classification systems for vasculitis.

When the validation study is complete, SQI will compile and analyze the data and intends to submit the results to the U.S. Food and Drug Administration seeking its clearance to market the Vasculitis IgX PLEX assay. 

“We are looking forward to the opportunity to work with SQI’s multiplexed technology because we see it as a tool that has the potential to more effectively and efficiently support the diagnoses of autoimmune diseases such as vasculitis,” said Dr. Falk. "As modern medicine continues its rapid evolution, working with companies such as SQI supports our commitment to leverage new and innovative laboratory testing solutions in order to enhance our leadership position in the field."

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